The Central government on Tuesday informed the Kerala High Court that no clinical trial or studies had been conducted in the country on administering more than two doses of COVID-19 vaccine.
In a statement filed in the High Court, the Centre submitted that so far, no specific recommendation regarding the COVID-19 vaccine booster/third dose had been made by the National Technical Advisory Group on Immunisation (NTAGI) and the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). Besides, the World Health Organisation (WHO) had not made any recommendation on administering a third dose or booster doses.
The statement was filed in response to a writ petition filed by an NRI employed in Saudi Arabia seeking a directive to administer him the internationally approved Covishield vaccine.
According to the petitioner, he would not be allowed to enter Saudi Arabia as the two shots of Covaxin taken by him had not been approved by the Saudi government.
The Centre submitted that, in fact, the efficacy and the safety profile of third dosage schedule had not been established. It said that Bharat Biotech International Limited (BBIL), manufacturer of Covaxin, had approached the WHO for its approval and presented the data and other documentation before it. The exact timeline for approval would depend on completion of the examination process by the WHO.
